Parastomal Reinforcement With Strattice

LifeCell120 enrolled

Overview

The purpose of this study is to compare the clinical outcomes of patients undergoing surgery for a permanent abdominal wall ostomy with and without placement of Strattice fascial inlay, as measured by postoperative occurence of parastomal hernia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

TRIPLE

Enrollment

120

Conditions

Parastomal Hernia

Interventions

Strattice Reconstructive MatrixDEVICE

Strattice will be placed as a fascial inlay to support stoma sites

Standard ostomy creationOTHER

Ostomy will be created as routinely performed

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * adults * need for permanent ileostomy or colostomy Exclusion Criteria: * history of hernia at new ostomy site * has previously implanted surgical mesh at site of planned ostomy * requires a temporary ostomy * has need for multiple ostomies * is receiving chronic immunosuppression therapy, has MELD score of \> 17, has severe COPD, systemic infection, or known collagen disorder * is bedridden or otherwise non-ambulatory

Locations (23)

University of South Alabama

Mobile, Alabama, United States

Outcomes

Primary Outcomes

Occurrence of Parastomal Hernia in Subjects Undergoing Permanent Abdominal Wall Ostomy Creation With and Without Strattice Fascial Inlay.

Time frame: 24 months

Secondary Outcomes

Stoma Complications

Time frame: 30 days

Stoma Complications

Time frame: more than 1 month postoperatively

Stoma Quality of Life

Time frame: Serially over 24 months

Data from ClinicalTrials.gov

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